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Trial to Assess Chelation Therapy 2 (TACT2)

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ClinicalTrials.gov Identifier: NCT02733185
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Duke Clinical Research Institute
Information provided by (Responsible Party):
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami

Brief Summary:
Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI).

Condition or disease Intervention/treatment Phase
Diabetes Myocardial Infarction Drug: disodium EDTA Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM) Drug: Placebo disodium EDTA Dietary Supplement: Placebo Oral Multi Vitamins/Minerals (OMVM) Phase 3

Detailed Description:

The primary objective of TACT2, therefore, is to determine if the chelation-based strategy increases the time to the first occurrence of any of the components of the TACT2 primary endpoint: all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina compared to the placebo chelation strategy.

TACT2 is a 2x2 factorial trial testing 40-weekly edetate disodium-based chelation infusions and twice daily high-dose oral multivitamins and multiminerals (OMVM) in a placebo-controlled design.

TACT2 is being carried out to replicate the findings of TACT1, which found a striking reduction of recurrent cardiovascular events in post-MI diabetic patients receiving edetate disodium-based chelation therapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Trial to Assess Chelation Therapy 2
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Active/Active
Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Drug: disodium EDTA
Other Name: EDTA

Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)
Active Comparator: Active/Placebo
Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Drug: disodium EDTA
Other Name: EDTA

Active Comparator: Placebo/ Active
Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)
Drug: Placebo disodium EDTA
Placebo Comparator: Placebo/Placebo
Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Drug: Placebo disodium EDTA
Dietary Supplement: Placebo Oral Multi Vitamins/Minerals (OMVM)



Primary Outcome Measures :
  1. A composite of all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina [ Time Frame: 5 years ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 50 years
  2. History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.
  3. History of myocardial infarction based on the Universal Definition of MI. 36

    1. When information about the MI hospitalization is available, all MI types except Type 2 qualify for study entry.
    2. When information about the MI hospitalization is not available, a wall motion abnormality on imaging or a perfusion defect on scan that corresponds to a coronary distribution, whether or not accompanied by pathological Q waves in the appropriate distribution, will qualify the patient for study entry. This criterion requires a call to the CCC for case review.

Exclusion Criteria:

  1. Baseline serum creatinine >2.0 mg/dL.
  2. HbA1C >11%.
  3. Myocardial infarction within 6 weeks of randomization.
  4. History of allergic reactions to EDTA or any other components of the chelation solution, including heparin.
  5. Coronary or peripheral arterial revascularization procedure performed within the last 6 months.
  6. Planned revascularization procedure in the 6 months following enrollment.
  7. Heart failure hospitalization within 6 months prior to enrollment or in clinical heart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea + rales>basilar, and additional signs of fluid overload). Such patients may be treated with diuretics and enrolled when stable.
  8. Poor or no venous access in the upper extremities.
  9. Prior intravenous chelation therapy within 5 years or oral chelation within 2 years of the time of proposed randomization.
  10. Prior participation in TACT1.
  11. Baseline platelet count <100,000.
  12. History of cigarette smoking within the last 3 months.
  13. ALT or AST > 2.0 times the upper limit of normal.
  14. Wilson's disease, hemochromatosis, or parathyroid disease.
  15. Any medical condition including a current diagnosis of cancer (except non-melanoma skin cancer) that will limit patient survival over the duration of the trial.
  16. Any factor that suggests that the potential participant will not be able to adhere to the protocol.
  17. Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733185


Contacts
Contact: Gervasio A Lamas, MD 305-674-2260 gervasio.lamas@msmc.com
Contact: Shawn Rosen Holtzman, MBA 305-674-2121 ext 50315 Shawn.Rosenholtzman@msmc.com

Locations
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33132
Contact: Ivan Arenas, MD    305-674-2162    Ivan.Arenas@msmc.com   
Contact: Ana Mon, MPH    305-674-3936    ana.mon@msmc.com   
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Duke Clinical Research Institute
Investigators
Study Chair: Gervasio A Lamas, MD Mount Sinai Medical Center of Florida
Principal Investigator: Kevin J Anstrom, PhD Duke University (Duke Clinical Research Institute)
Principal Investigator: Daniel B Mark, MD Duke University (Duke Clinical Research Institute)

Publications:
Responsible Party: Gervasio Lamas, MD, TACT2 Study Chair, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT02733185     History of Changes
Other Study ID Numbers: AT009149-01
UH3AT009149 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami:
chelation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Vitamins
Edetic Acid
Pentetic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Iron Chelating Agents